A kind of acyclovir cream and preparation method thereof

A technology of acyclovir cream and emulsifier, applied in the direction of ointment delivery, emulsion delivery, aerosol delivery, etc., to achieve the effect of increasing effectiveness and safety, good effect and stable properties

Active Publication Date: 2016-03-23
湖北科益药业股份有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0004] The acyclovir emulsifiable cream that existing method prepares all has very big limitation, long-term use high-concentration propylene glycol, can have influence on epidermal sebum structure; Dimethyl sulfoxide then has stronger skin irritation, gives a The clinical use of ciclovir cream brings safety risks

Method used

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  • A kind of acyclovir cream and preparation method thereof
  • A kind of acyclovir cream and preparation method thereof
  • A kind of acyclovir cream and preparation method thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0043] A kind of Acyclovir emulsifiable paste, its raw material formula is composed as follows:

[0044]

[0045] The raw material of above-mentioned formula is prepared into the method step of acyclovir as follows:

[0046] (1) Weigh the oil phase components cetearyl alcohol, white petrolatum and liquid paraffin respectively according to the raw material formula, heat to 75-80°C and mix well to obtain the oil phase.

[0047] (2) Dissolve sodium hydroxide in purified water, then add acyclovir, stir to dissolve, then add poloxamer 188 and sodium lauryl sulfate, stir to dissolve, heat to 75-80°C to obtain an aqueous phase.

[0048] (3) Add the water phase to the oil phase, stir for 15 minutes to homogenize, and when the homogenization is completed, cool down to 40-45°C while stirring to obtain a cream base.

[0049] (4) Dissolve citric acid in propylene glycol, then add the resulting solution into the cream base under stirring, and stir evenly.

[0050] (5) Continue to stir...

Embodiment 2

[0053] A kind of Acyclovir emulsifiable paste, its raw material formula is composed as follows:

[0054]

[0055] The preparation method is the same as in Example 1.

[0056] The prepared emulsifiable paste is milky white, pH5.2, microscopic observation, no acyclovir raw material drug crystals are found, and the particle diameter of the emulsifiable emulsifiable milk droplet is all less than 8 μ m, centrifuged at 3000rpm for 30 minutes, no stratification, no demulsification.

Embodiment 3

[0058] A kind of Acyclovir emulsifiable paste, its raw material formula is composed as follows:

[0059]

[0060]

[0061] The preparation method is the same as in Example 1.

[0062] The prepared emulsifiable paste is milky white, pH 5.1, microscopic observation, no crystals of acyclovir raw material drug are found, and the particle diameter of emulsifiable milk drops is all less than 8 μm, centrifuged at 3000rpm for 30 minutes, no stratification, no demulsification.

[0063] The Acyclovir cream that above-mentioned embodiment 1-3 makes has carried out pharmacodynamics research:

[0064] With the commercially available aciclovir cream as the positive control group, with the blank matrix in Example 1 as the negative control group, using local hair removal and transdermal administration, the anti-inflammatory effect in the guinea pig skin HSV-1 herpes model was studied. Viral effect. The research results show that the cream prepared by the invention has better medicinal...

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Abstract

The invention relates to the technical field of pharmaceutical preparations, and particularly discloses an acyclovir emulsifiable paste and a preparation method thereof. The acyclovir emulsifiable paste comprises acyclovir, an oil phase substrate, an emulgator, a cosolvent, an acid-base buffer system, a humectant and water, wherein the oil phase substrate is a mixture of liquid paraffin, cetearyl alcohol and albolene, the cosolvent is poloxamer 188, and the acid-base buffer system is a citric acid-sodium hydroxide system. By combining the improvements of the formula and preparation method, the acyclovir can be dissolved in emulsifiable paste substrate, thus having better anti-herpes virus effect, high safety and good stability.

Description

technical field [0001] The invention relates to the technical field of pharmaceutical preparations, in particular to an acyclovir cream and a preparation method thereof. Background technique [0002] Acyclovir is a nucleoside antiviral drug that can inhibit herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2) in vitro and in vivo. Topical application in the treatment of herpes simplex or herpes zoster infection. There are preparations such as acyclovir emulsifiable paste on the market both at home and abroad, but because acyclovir is neither water-soluble, but also insoluble in general organic solvents, so when preparing acyclovir emulsifiable paste, it is difficult to mix acyclovir Wei is dispersed in the cream base to achieve effective local penetration to ensure curative effect. [0003] European patent application EP44543, which relates to an oil-in-water formulation of the antiviral agent acyclovir, states that a carrier containing at least 30 w...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/06A61K31/522A61P31/22
Inventor 舒志元余修祥邓彬李霞江强
Owner 湖北科益药业股份有限公司
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